BMS-741672 for Diabetic Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.

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Detailed Description

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

BMS-741672

Intervention Type DRUG

Tablets, Oral, 100 mg, once daily, 3 weeks

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up

Interventions

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BMS-741672

Tablets, Oral, 100 mg, once daily, 3 weeks

Intervention Type DRUG

Placebo

Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 or 2 diabetics with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration
* Screening HbA1c of ≥ 7% and ≤ 10%
* BMI ≤ 40 kg/m2

Exclusion Criteria

* Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, central nervous system (CNS), psychiatric, endocrine (other than diabetes), tuberculosis or renal
* Women of childbearing potential

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No